Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301

Parenteral Nutrition Clinical Trial

Official title:

A Randomized, Open-label, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301 in Postoperative Patients Requiring Peripheral Parenteral Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05337228
• Other study ID #: IN_PPN_301
• Status: Completed
• Phase: Phase 3
• Start date: August 9, 2022
• Est. completion date: February 24, 2023

Study information

• Verified date: February 2023
• Source: HK inno.N Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 in postoperative patients requiring central parenteral nutrition.

Description:

This study is a randomized, open-label, phase 3 design. The subject will be assigned to one of the two treatment groups (IN-C006 Peri inj. or RPN301)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 24, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age over 19 at the time of obtaining the informed consent form

• Requiring over 3 days of parenteral nutrition via a peripheral vein after an operation

• BMI 16 ~ 30 kg/?

Exclusion Criteria:

• Has received parenteral nutrition within 7 days of screening

• Severe dyslipidemia

• Uncontrolled diabetes

• Clinically significant liver disease

• Clinically significant kidney disease

Related Conditions & MeSH terms

• Parenteral Nutrition

Intervention

Drug:
• IN-C006 Peri inj.
IN-C006 peri inj. will be injected continuously for 3 days.
• RPN301
RPN301 will be injected continuously for 3 days.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse drug reaction rate	Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation	Day 1 to Day 4
Secondary	Change in nutritional management parameters(Nitrogen balance)	Nitrogen balance(Nitrogen intake-Nitrogen out)	Day 1 to Day 4
Secondary	Change in nutritional management parameters(Prealbumin)	Prealbumin(mg/L)	Day 1 to Day 4
Secondary	Change in nutritional management parameters(Albumin)	Albumin(g/dL)	Day 1 to Day 4
Secondary	Change in nutritional management parameters(Transferrin)	Transferrin(mg/dL)	Day 1 to Day 4
Secondary	Change in inflammation parameters(hs-CRP)	hs-CRP(mg/L)	Day 1 to Day 4
Secondary	Change in inflammation parameters(TNF-a)	TNF-a(pg/mL)	Day 1 to Day 4
Secondary	Change in inflammation parameters(IL-6)	IL-6(pg/mL)	Day 1 to Day 4
Secondary	Change in fatty acid profile	LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL)	Day 1 to Day 4
Secondary	Incidence of Adverse event	Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation	Day 1 to Day 4
Secondary	Change in laboratory parameters (Hematology)	Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group; - Hematology	Day 1 to Day 4
Secondary	Change in laboratory parameters (Blood chemistry)	Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group; - Blood chemistry	Day 1 to Day 4
Secondary	Change in laboratory parameters (Blood coagulation test)	Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group; - Blood coagulation test	Day 1 to Day 4
Secondary	Change in laboratory parameters (Urinalysis)	Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group; - Urinalysis	Day 1 to Day 4
Secondary	Change in vital sign (Blood pressure)	Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)); - Systolic blood pressure(mmHg), Diastolic blood pressure(mmHg)	Day 1 to Day 4
Secondary	Change in vital sign (Pulse rate)	Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)); - Pulse rate(rate)	Day 1 to Day 4
Secondary	Change in vital sign (Body temperature)	Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)); - Body temperature(?)	Day 1 to Day 4
Secondary	Change in vital sign (Respiratory rate)	Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)); - Respiratory rate(rate)	Day 1 to Day 4
Secondary	Normal and abnormal change in physical examination (Frequency)	Frequency of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products; - General Appearance, HEENT (Head, Eyes, Ears, Nose, Throat), Skin (including hair, nails), Respiratory, Cardiovascular, Chest/Lungs/Breast, Abdominal/Gastrointestinal, Musculoskeletal, Extremities/Joint, Neurological/Psychological, Lymph nodes, Rectal/Pelvic/Genitalia, Other	Day 1 to Day 4
Secondary	Normal and abnormal change in physical examination (Ratio)	Ratio of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products; - General Appearance, HEENT (Head, Eyes, Ears, Nose, Throat), Skin (including hair, nails), Respiratory, Cardiovascular, Chest/Lungs/Breast, Abdominal/Gastrointestinal, Musculoskeletal, Extremities/Joint, Neurological/Psychological, Lymph nodes, Rectal/Pelvic/Genitalia, Other	Day 1 to Day 4